BLeeding Events and Maintenance DoSe of PraSugrel (BLESS)
This study is currently recruiting participants.
Verified February 2013 by Careggi Hospital
Sponsor:
David Antoniucci
Collaborator:
ARCARD ONLUS Foundation
Information provided by (Responsible Party):
David Antoniucci, Careggi Hospital
ClinicalTrials.gov Identifier:
NCT01790854
First received: February 12, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
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Purpose
Aim: to verify if after the acute phase of ACS acute coronary syndrome (1-months), from 1 to 12 months the reduction of maintenance dose of prasugrel from 10 mg to 5 mg/day may reduce the bleeding events (5 mg vs 10 mg). All patients will be treated with 325 mg of aspirin followed by a maintenance dosage of 100 mg of aspirin for at least 1 year. At baseline (after 60 mg loading dose of prasugrel) and after 1 month (7 days after the randomization at 10 or 5 mg of prasugrel) all patients will undergo light transmittance aggregometry (LTA) test to evaluate residual platelet reactivity (pharmacodynamic effects).
| Condition | Intervention | Phase |
|---|---|---|
|
Adverse Reaction to Antiplatelet Agent Acute Coronary Syndrome |
Drug: Prasugrel dose 5 mg/day Drug: Prasugrel dose 10 mg/day |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bless Study (BLeeding Events and Maintenance DoSe of PraSugrel) |
Further study details as provided by Careggi Hospital:
Primary Outcome Measures:
- bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]major, minor and minimal bleeding defined according BARC (Bleeding Academic Research Consurtium criteria (11), occurring from 1 month to the end of the study.
Secondary Outcome Measures:
- MACE [ Time Frame: 12 months ] [ Designated as safety issue: No ]MACE (cardiac death, Myocardial Infarction, stroke) occurring from 1 month to the end of the study; late stent thrombosis.
Other Outcome Measures:
- pharmacodynamic effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]pharmacodynamic effects of shifting prasugrel maintenance dose from 10 mg to 5 mg after ACS
- residual platelet reactivity (LTA) [ Time Frame: baseline - 1 month ] [ Designated as safety issue: Yes ]correlation between residual platelet reactivity (LTA), both at baseline and at 1-month, with bleeding and ischemic events
| Estimated Enrollment: | 450 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prasugrel dose 5 mg/day
225 patients will be treated with 325 mg of aspirin (followed by a maintenance dosage of 100 mg of aspirin for at least 1 year and with 60 mg loading dose of prasugrel followed by a maintenance dosage of 5 mg/day of prasugrel for 12 months
|
Drug: Prasugrel dose 5 mg/day |
|
Active Comparator: Prasugrel dose 10 mg/day
225 patients will be treated with 325 mg of aspirin (followed by a maintenance dosage of 100 mg of aspirin for at least 1 year and with 60 mg loading dose of prasugrel followed by a maintenance dosage of 10 mg/day of prasugrel for 12 months
|
Drug: Prasugrel dose 10 mg/day |
Eligibility| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- all ACS patients treated with PCI (percutaneous coronary intervention) and dual antiplatelet therapy (DAPT: aspirin plus prasugrel).
- Informed written consent
Exclusion Criteria:
- Age < 18 years
- Active bleeding; bleeding diathesis; coagulopathy
- History of gastrointestinal or genitourinary bleeding <2 months
- Major surgery in the last 6 weeks
- History of intracranial bleeding or structural abnormalities
- Suspected aortic dissection
- Any previous TIA (transient ischemic attack)/stroke
- Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux .
- Known relevant hematological deviations: Hb <10 g/dl, Thrombocytopenia. <100x10^9/l
- Use of coumadin derivatives within the last 7 days
- Chronic therapy with prasugrel or ticagrelor
- Known malignancies or other comorbid conditions with life expectancy <1 year
- Known severe liver disease, severe renal failure
- Known allergy to the study medications
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790854
Contacts
| Contact: David Antoniucci, MD | +390557947966 | david.antoniucci@virgilio.it |
| Contact: Nazario Carrabba, MD | +390557947966 | n.carrabba@virgilio.it |
Locations
| Italy | |
| Careggi Hospital | Recruiting |
| Florence, Italy | |
| Contact: David Antoniucci, MD +390557947966 david.antoniucci@virgilio.it | |
| Contact: Nazario Carrabba, MD +390557947966 n.carrabba@virgilio.it | |
| Principal Investigator: David Antoniucci, MD | |
Sponsors and Collaborators
David Antoniucci
ARCARD ONLUS Foundation
Investigators
| Principal Investigator: | David Antoniucci, MD | Careggi Hospital, division of Invasive Cardiology |
More Information
No publications provided
| Responsible Party: | David Antoniucci, Head Division of Invasive Cardiology, Careggi Hospital |
| ClinicalTrials.gov Identifier: | NCT01790854 History of Changes |
| Other Study ID Numbers: | BLESS Study |
| Study First Received: | February 12, 2013 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by Careggi Hospital:
|
prasugrel antiplatelet Acute Coronary Syndrome |
Additional relevant MeSH terms:
|
Hemorrhage Acute Coronary Syndrome Pathologic Processes Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain |
Signs and Symptoms Prasugrel Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013